Premature BirthNCT04383340
Sensitivity Training for Parents With Premature Infants
A study testing Mother-Infant Transaction Program and Treatment as usual in people with Premature Birth, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study evaluated the effectiveness of a culturally adapted version of the Mother-Infant Transaction Program (MITP) among Chinese mothers with premature infants in public hospitals in Hong Kong. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- Mother-Infant Transaction Program and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2018to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mothers with premature infants born at 36 weeks or earlier
Who cannot join
- insufficient spoken and written Chinese ability of the mother
- mother under 18 years of age
- triplets or higher multiples
- infants with congenital abnormalities (e.g., metabolic disorder, chromosomal disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sensitivity Training for Mothers With Premature Infants: A Randomized Controlled Trial
This study evaluated the effectiveness of a culturally adapted version of the Mother-Infant Transaction Program (MITP) among Chinese mothers with premature infants in public hospitals in Hong Kong.
Read the detailed description
Potential participants at two public hospitals in Hong Kong were identified by ward nurses. Mother-infant dyads with infants born at 36 weeks or earlier were assessed for eligibility. Data collection was conducted after obtaining written consent from the mothers. Mother-infant dyads who met the inclusion criteria were randomly allocated to either the intervention or the treatment-as-usual control group. Each dyad was assessed at six time points, i.e., baseline, immediately after intervention/TAU, and when the infants were at the gestation-corrected ages of 3, 6, 9, and 12 months.
- Conditions
- Premature Birth
- Being tested
- Mother-Infant Transaction Program, Treatment as usual
- Keywords
- sensitivity training, mother-infant interaction
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mother-Infant Transaction ProgramBehavioural
Parent sensitivity training for mothers of premature infants
Treatment as usualBehavioural
Standard hospital care and parental support
| Study group | Role | What they receive |
|---|---|---|
| Mother-Infant Transaction Program | Experimental | Four sessions were delivered to the mothers one-on-one based on a manualized protocol while the infants were still in the neonatal intensive care units. These coaching sessions included psychological care for the mother and topics on recognizing premature infant's characteristics, understanding and recognizing signs of infant stress and infant's engagement and disengagement cues, principles of graded stimulation, and how to optimize interactions and avoid over-stimulating the infant. Receives: Behavioral: Mother-Infant Transaction Program |
| Treatment as usual | Active comparator | For this group, infants and mothers received standard hospital care following the initial baseline assessment; these mothers were invited to ask questions about recommended ways to take care of their infants, but no specific knowledge or skills targeted by the adapted MITP program were taught Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral observation of mother-infant interactions
Maternal sensitivity and quality of mother-infant interaction measured by coding a 5-min video of mother-infant interaction. The coded variables are rated on a 5-point scale, and higher scores indicate higher maternal sensitivity and better interaction quality.
Measured: At baseline prior to intervention
Behavioral observation of mother-infant interactions
Maternal sensitivity and quality of mother-infant interaction measured by coding a 5-min video of mother-infant interaction. The coded variables are rated on a 5-point scale, and higher scores indicate higher maternal sensitivity and better interaction quality.
Measured: Immediately after intervention
Behavioral observation of mother-infant interactions
Maternal sensitivity and quality of mother-infant interaction measured by coding a 5-min video of mother-infant interaction. The coded variables are rated on a 5-point scale, and higher scores indicate higher maternal sensitivity and better interaction quality.
Measured: At infant's corrected age of 3 months
Behavioral observation of mother-infant interactions
Maternal sensitivity and quality of mother-infant interaction measured by coding a 5-min video of mother-infant interaction. The coded variables are rated on a 5-point scale, and higher scores indicate higher maternal sensitivity and better interaction quality.
Measured: At infant's corrected age of 6 months
Maternal postnatal depression
Maternal depression measured by the Edinburgh Postnatal Depression Scale. Possible scores range from 0 to 30. Higher scores indicate higher levels of depression.
Measured: At baseline prior to intervention
Maternal postnatal depression
Maternal depression measured by the Edinburgh Postnatal Depression Scale. Possible scores range from 0 to 30. Higher scores indicate higher levels of depression.
Measured: Immediately after intervention
Maternal postnatal depression
Maternal depression measured by the Edinburgh Postnatal Depression Scale. Possible scores range from 0 to 30. Higher scores indicate higher levels of depression.
Measured: At infant's corrected age of 3 months
Maternal postnatal depression
Maternal depression measured by the Edinburgh Postnatal Depression Scale. Possible scores range from 0 to 30. Higher scores indicate higher levels of depression.
Measured: At infant's corrected age of 6 months
Parenting stress
Parenting stress measured by the Parenting Stress Index-Short Form. Possible scores range from 36 to 180. Higher scores indicate higher levels of parenting stress.
Measured: At baseline prior to intervention
Parenting stress
Parenting stress measured by the Parenting Stress Index-Short Form. Possible scores range from 36 to 180. Higher scores indicate higher levels of parenting stress.
Measured: Immediately after intervention
Parenting stress
Parenting stress measured by the Parenting Stress Index-Short Form. Possible scores range from 36 to 180. Higher scores indicate higher levels of parenting stress.
Measured: At infant's corrected age of 3 months
Parenting stress
Parenting stress measured by the Parenting Stress Index-Short Form. Possible scores range from 36 to 180. Higher scores indicate higher levels of parenting stress.
Measured: At infant's corrected age of 6 months
Infant's temperament
Infant's soothability based on the Infant Behavior Questionnaire. A higher average score denotes higher soothability of the infant, and the highest possible score is 7.
Measured: At baseline prior to intervention
Infant's temperament
Infant's soothability based on the Infant Behavior Questionnaire. A higher average score denotes higher soothability of the infant, and the highest possible score is 7.
Measured: Immediately after intervention
Infant's temperament
Infant's soothability based on the Infant Behavior Questionnaire. A higher average score denotes higher soothability of the infant, and the highest possible score is 7.
Measured: At infant's corrected age of 3 months
Infant's temperament
Infant's soothability based on the Infant Behavior Questionnaire. A higher average score denotes higher soothability of the infant, and the highest possible score is 7.
Measured: At infant's corrected age of 6 months
Infant's weight gain
Infant's weight gain from birth
Measured: At infant's corrected age of 3 months
Infant's weight gain
Infant's weight gain from birth
Measured: At infant's corrected age of 6 months
Infant's weight gain
Infant's weight gain from birth
Measured: At infant's corrected age of 9 months
Infant's weight gain
Infant's weight gain from birth
Measured: At infant's corrected age of 12 months
Infant's developmental outcomes
Measured by the Cognitive Battery of the Merrill-Palmer-Revised Scales of Development, which includes assessments in the cognitive, receptive language, and fine motor domains. Higher scores denote better performance in the assessments
Measured: At infant's corrected age of 3 months
Infant's developmental outcomes
Measured by the Cognitive Battery of the Merrill-Palmer-Revised Scales of Development, which includes assessments in the cognitive, receptive language, and fine motor domains. Higher scores denote better performance in the assessments
Measured: At infant's corrected age of 6 months
Infant's developmental outcomes
Measured by the Cognitive Battery of the Merrill-Palmer-Revised Scales of Development, which includes assessments in the cognitive, receptive language, and fine motor domains. Higher scores denote better performance in the assessments
Measured: At infant's corrected age of 9 months
Infant's developmental outcomes
Measured by the Cognitive Battery of the Merrill-Palmer-Revised Scales of Development, which includes assessments in the cognitive, receptive language, and fine motor domains. Higher scores denote better performance in the assessments
Measured: At infant's corrected age of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Feb 2018
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Responsible party
- Sponsor
- Investigators
- Terry Au, PhD, Study director, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383340
- Sponsor's protocol ID
- KCC/RC/G/1819-B03
- Status last verified
- May 2020
- First submitted
- 5 May 2020
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Publications
Yu NKK, Shum KK, Lam YY, Kwan QKL, Ng SYP, Chan NTT. Sensitivity Training for Mothers With Premature Infants: A Randomized Controlled Trial. J Pediatr Psychol. 2022 Oct 19;47(10):1167-1184. doi: 10.1093/jpepsy/jsac051.
PubMed 35666133
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity Training for Mothers With Premature Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04383340
- Acronym / sponsor ID
- KCC/RC/G/1819-B03
- Conditions
- Premature Birth
- Keywords
- sensitivity training, mother-infant interaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated the effectiveness of a culturally adapted version of the Mother-Infant Transaction Program (MITP) among Chinese mothers with premature infants in public hospitals in Hong Kong.
Detailed description
Potential participants at two public hospitals in Hong Kong were identified by ward nurses. Mother-infant dyads with infants born at 36 weeks or earlier were assessed for eligibility. Data collection was conducted after obtaining written consent from the mothers. Mother-infant dyads who met the inclusion criteria were randomly allocated to either the intervention or the treatment-as-usual control group. Each dyad was assessed at six time points, i.e., baseline, immediately after intervention/TAU, and when the infants were at the gestation-corrected ages of 3, 6, 9, and 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Mother-Infant Transaction Program | Experimental | Behavioral: Mother-Infant Transaction ProgramFour sessions were delivered to the mothers one-on-one based on a manualized protocol while the infants were still in the neonatal intensive care units. These coaching sessions included psychological care for the mother and topics on recognizing premature infant's characteristics, understanding and recognizing signs of infant stress and infant's engagement and disengagement cues, principles of graded stimulation, and how to optimize interactions and avoid over-stimulating the infant. |
| Treatment as usual | Active comparator | Behavioral: Treatment as usualFor this group, infants and mothers received standard hospital care following the initial baseline assessment; these mothers were invited to ask questions about recommended ways to take care of their infants, but no specific knowledge or skills targeted by the adapted MITP program were taught |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mothers with premature infants born at 36 weeks or earlier
Key exclusion criteria (4 listed)
- insufficient spoken and written Chinese ability of the mother
- mother under 18 years of age
- triplets or higher multiples
- infants with congenital abnormalities (e.g., metabolic disorder, chromosomal disorder)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mother-Infant Transaction ProgramParent sensitivity training for mothers of premature infants | Behavioural | Mother-Infant Transaction Program |
| Treatment as usualStandard hospital care and parental support | Behavioural | Treatment as usual |
Primary outcome
Behavioral observation of mother-infant interactions
Time frame: At baseline prior to intervention
Maternal sensitivity and quality of mother-infant interaction measured by coding a 5-min video of mother-infant interaction. The coded variables are rated on a 5-point scale, and higher scores indicate higher maternal sensitivity and better interaction quality.
Behavioral observation of mother-infant interactions
Time frame: Immediately after intervention
Maternal sensitivity and quality of mother-infant interaction measured by coding a 5-min video of mother-infant interaction. The coded variables are rated on a 5-point scale, and higher scores indicate higher maternal sensitivity and better interaction quality.
Behavioral observation of mother-infant interactions
Time frame: At infant's corrected age of 3 months
Maternal sensitivity and quality of mother-infant interaction measured by coding a 5-min video of mother-infant interaction. The coded variables are rated on a 5-point scale, and higher scores indicate higher maternal sensitivity and better interaction quality.
Behavioral observation of mother-infant interactions
Time frame: At infant's corrected age of 6 months
Maternal sensitivity and quality of mother-infant interaction measured by coding a 5-min video of mother-infant interaction. The coded variables are rated on a 5-point scale, and higher scores indicate higher maternal sensitivity and better interaction quality.
Maternal postnatal depression
Time frame: At baseline prior to intervention
Maternal depression measured by the Edinburgh Postnatal Depression Scale. Possible scores range from 0 to 30. Higher scores indicate higher levels of depression.
Maternal postnatal depression
Time frame: Immediately after intervention
Maternal depression measured by the Edinburgh Postnatal Depression Scale. Possible scores range from 0 to 30. Higher scores indicate higher levels of depression.
Maternal postnatal depression
Time frame: At infant's corrected age of 3 months
Maternal depression measured by the Edinburgh Postnatal Depression Scale. Possible scores range from 0 to 30. Higher scores indicate higher levels of depression.
Maternal postnatal depression
Time frame: At infant's corrected age of 6 months
Maternal depression measured by the Edinburgh Postnatal Depression Scale. Possible scores range from 0 to 30. Higher scores indicate higher levels of depression.
Parenting stress
Time frame: At baseline prior to intervention
Parenting stress measured by the Parenting Stress Index-Short Form. Possible scores range from 36 to 180. Higher scores indicate higher levels of parenting stress.
Parenting stress
Time frame: Immediately after intervention
Parenting stress measured by the Parenting Stress Index-Short Form. Possible scores range from 36 to 180. Higher scores indicate higher levels of parenting stress.
Parenting stress
Time frame: At infant's corrected age of 3 months
Parenting stress measured by the Parenting Stress Index-Short Form. Possible scores range from 36 to 180. Higher scores indicate higher levels of parenting stress.
Parenting stress
Time frame: At infant's corrected age of 6 months
Parenting stress measured by the Parenting Stress Index-Short Form. Possible scores range from 36 to 180. Higher scores indicate higher levels of parenting stress.
Infant's temperament
Time frame: At baseline prior to intervention
Infant's soothability based on the Infant Behavior Questionnaire. A higher average score denotes higher soothability of the infant, and the highest possible score is 7.
Infant's temperament
Time frame: Immediately after intervention
Infant's soothability based on the Infant Behavior Questionnaire. A higher average score denotes higher soothability of the infant, and the highest possible score is 7.
Infant's temperament
Time frame: At infant's corrected age of 3 months
Infant's soothability based on the Infant Behavior Questionnaire. A higher average score denotes higher soothability of the infant, and the highest possible score is 7.
Infant's temperament
Time frame: At infant's corrected age of 6 months
Infant's soothability based on the Infant Behavior Questionnaire. A higher average score denotes higher soothability of the infant, and the highest possible score is 7.
Infant's weight gain
Time frame: At infant's corrected age of 3 months
Infant's weight gain from birth
Infant's weight gain
Time frame: At infant's corrected age of 6 months
Infant's weight gain from birth
Infant's weight gain
Time frame: At infant's corrected age of 9 months
Infant's weight gain from birth
Infant's weight gain
Time frame: At infant's corrected age of 12 months
Infant's weight gain from birth
Infant's developmental outcomes
Time frame: At infant's corrected age of 3 months
Measured by the Cognitive Battery of the Merrill-Palmer-Revised Scales of Development, which includes assessments in the cognitive, receptive language, and fine motor domains. Higher scores denote better performance in the assessments
Infant's developmental outcomes
Time frame: At infant's corrected age of 6 months
Measured by the Cognitive Battery of the Merrill-Palmer-Revised Scales of Development, which includes assessments in the cognitive, receptive language, and fine motor domains. Higher scores denote better performance in the assessments
Infant's developmental outcomes
Time frame: At infant's corrected age of 9 months
Measured by the Cognitive Battery of the Merrill-Palmer-Revised Scales of Development, which includes assessments in the cognitive, receptive language, and fine motor domains. Higher scores denote better performance in the assessments
Infant's developmental outcomes
Time frame: At infant's corrected age of 12 months
Measured by the Cognitive Battery of the Merrill-Palmer-Revised Scales of Development, which includes assessments in the cognitive, receptive language, and fine motor domains. Higher scores denote better performance in the assessments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Derived from this study: PubMed 35666133Yu NKK, Shum KK, Lam YY, Kwan QKL, Ng SYP, Chan NTT. Sensitivity Training for Mothers With Premature Infants: A Randomized Controlled Trial. J Pediatr Psychol. 2022 Oct 19;47(10):1167-1184. doi: 10.1093/jpepsy/jsac051.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry Au, PhD study director
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mother-Infant Transaction Program and Treatment as usual in people with Premature Birth, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral observation of mother-infant interactions (time frame: At baseline prior to intervention). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04383340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022; AzTrials last refreshed its copy on 26 Oct 2026.